Type 2 DiabetesNCT07332156
Lung Cancer Risk in Type 2 Diabetes With COPD: SGLT2 Inhibitors vs. Sulfonylureas
An observational study of Type 2 Diabetes and COPD (Chronic Obstructive Pulmonary Disease), run by Samsung Medical Center.
Trial summary
The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Type 2 Diabetes, COPD (Chronic Obstructive Pulmonary Disease), Lung Cancer (Diagnosis)
- What is being tested?
- SGLT2 inhibitor, Sulfonylureas (SU) and DPP4 inhibitors
- How many people
- 21,692 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included adults aged ≥40 years with a prior history of COPD (screened from 2009) and newly diagnosed type 2 diabetes who initiated treatment with either sulfonylureas or SGLT2 inhibitors between January 1, 2014, and December 31, 2023. Type 2 diabetes was defined as having two or more diagnosis records within one year using ICD-10 codes E10-E14. COPD was defined by the presence of ICD-10 codes J43 or J44 (excluding J43.0) concurrent with the prescription of COPD medications at least twice within a year; these medications included long-acting muscarinic antagonists (LAMA), long-acting beta-2 agonists (LABA), ICS plus LABA, short-acting muscarinic antagonists (SAMA), short-acting beta-2 agonists (SABA), SAMA plus SABA, methylxanthines, and systemic beta agonists. In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.
Who may be able to join
- Adults aged ≥40 years with prior COPD (from 2009) and newly diagnosed diabetes who initiated SU or SGLT2i between January 1, 2014 and December 31, 2023
Who cannot join
- Pre-existing
- ESRD
- Cancer
- Concurrent prescribing of the study drugs at the index date
- Exposure to the drugs of interest during the year preceding the index date
- Death or cancer incidence within a month
- In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.
About this study
Official title: Lung Cancer Incidence in Patients With Type 2 Diabetes and COPD: A Real-World Retrospective Cohort Study Comparing SGLT2 Inhibitors and Sulfonylureas
The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD).
The main question it aims to answer is:
Read more
- Does taking medicines called SGLT2 inhibitors lower the chance of getting lung cancer compared to medicines called sulfonylureas?
Researchers will compare the medical records of people taking SGLT2 inhibitors to those taking sulfonylureas to see if the SGLT2 group has fewer cases of lung cancer.
Participants will not need to visit a doctor or take new medicines for this study. Researchers will use information from existing medical records to answer the research question.
Read the detailed description
Study Design: This is a comparative effectiveness research study utilizing large-scale, population-based Real-World Data (RWD). By analyzing longitudinal data from existing medical records, researchers will emulate a target trial to minimize bias and provide robust estimates of the treatment effect.
Statistical Analysis Plan: The study employs a rigorous analytic framework consisting of a primary analysis and multiple sensitivity analyses to ensure the validity of the findings:
Primary Analysis: A comparison of SGLT2 inhibitors versus sulfonylureas using an Intention-To-Treat (ITT) framework, with follow-up censored upon treatment switching to estimate the effect of the initial treatment choice.
Sensitivity Analysis 1 (Active Comparator): A comparison of DPP-4 inhibitors versus SGLT2 inhibitors using the same ITT framework (censoring on switching) to assess the consistency of the results against an alternative second-line antidiabetic class.
Sensitivity Analysis 2 (As-Treated): A comparison of SGLT2 inhibitors versus sulfonylureas using an As-Treated approach, defining continuous use with a permissible gap (grace period) of 60 days between prescriptions to account for adherence patterns.
Significance and Impact Current guidelines for diabetes management prioritize cardiovascular and renal protection. This study aims to expand the clinical evidence base by:
- Providing actionable Real-World Evidence (RWE) on the long-term cancer-related outcomes of diabetes medications.
- Evaluating whether the choice of antidiabetic agents can serve as a strategy for lung cancer prevention in high-risk groups (COPD-T2DM).
- Contributing to the development of comprehensive treatment guidelines that consider cancer prevention alongside metabolic, cardiac, and renal health.
Abbreviation:
COPD, Chronic Obstructive Pulmonary Disease; DPP-4, Dipeptidyl Peptidase-4; ICD-10, International Classification of Diseases, 10th Revision; ICS, Inhaled Corticosteroids; ITT, Intention-To-Treat; LABA, Long-Acting Beta-2 Agonists; LAMA, Long-Acting Muscarinic Antagonists; RWD, Real-World Data; RWE, Real-World Evidence; SABA, Short-Acting Beta-2 Agonists; SAMA, Short-Acting Muscarinic Antagonists; SGLT2, Sodium-Glucose Cotransporter-2; SU, Sulfonylurea; T2DM, Type 2 Diabetes Mellitus;
- Being tested
- SGLT2 inhibitor, Sulfonylureas (SU), DPP4 inhibitors
- Keywords
- SGLT2 inhibitor, Sulfonylurea, T2DM with COPD, Lung cancer
- Medical subject headings
- Diabetes Mellitus, Type 2, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Any new prescription of SGLT2 inhibitors after new onset of T2DM
Sulfonylureas (SU)Drug
Any new prescription of sulfonylureas after new onset of T2DM
DPP4 inhibitorsDrug
Any new prescription of DPP4 inhibitors after new onset of T2DM
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (main) | Users of SGLT2 inhibitors (for ITT analysis) Receives: Drug: SGLT2 inhibitor | |
| Active control group (main) | Users of sulfonylureas for ITT analysis Receives: Drug: Sulfonylureas (SU) | |
| Treatment group (S1) | Users of SGLT2 inhibitors (for ITT analysis) Receives: Drug: SGLT2 inhibitor | |
| Active control group (S1) | Users of DPP4 inhibitors (for ITT analysis) Receives: Drug: Sulfonylureas (SU) | |
| Treatment group (S2) | Users of SGLT2 inhibitors (for as-treated analysis) Receives: Drug: SGLT2 inhibitor | |
| Active control group (S2) | Users of sulfonylureas (for as-treated analysis) Receives: Drug: DPP4 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung cancer
ICD-10 code (C33 or C34) and code for special purposes (V193)
Measured: From index date + 30 days to the end of follow-up
Secondary outcomes (2)
COPD exacerbation
COPD (J43 or J44, not J43.0) and antibiotics or steroids prescription and (emergency department or admission)
Measured: From index date + 30 days to the end of follow-up
Any cancer
ICD-10 code ('C' code) and code for special purposes (V193)
Measured: From index date + 30 days to the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2009
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danbee Kang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332156
- Sponsor's protocol ID
- SU vs. SGLT2 in T2DM with COPD
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Incidence in Patients With Type 2 Diabetes and COPD: A Real-World Retrospective Cohort Study Comparing SGLT2 Inhibitors and Sulfonylureas
- ClinicalTrials.gov ID
- NCT07332156
- Acronym / sponsor ID
- SU vs. SGLT2 in T2DM with COPD
- Keywords
- SGLT2 inhibitor, Sulfonylurea, T2DM with COPD, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,692 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD).
The main question it aims to answer is:
- Does taking medicines called SGLT2 inhibitors lower the chance of getting lung cancer compared to medicines called sulfonylureas?
Researchers will compare the medical records of people taking SGLT2 inhibitors to those taking sulfonylureas to see if the SGLT2 group has fewer cases of lung cancer.
Participants will not need to visit a doctor or take new medicines for this study. Researchers will use information from existing medical records to answer the research question.
Detailed description
Study Design: This is a comparative effectiveness research study utilizing large-scale, population-based Real-World Data (RWD). By analyzing longitudinal data from existing medical records, researchers will emulate a target trial to minimize bias and provide robust estimates of the treatment effect.
Statistical Analysis Plan: The study employs a rigorous analytic framework consisting of a primary analysis and multiple sensitivity analyses to ensure the validity of the findings:
Primary Analysis: A comparison of SGLT2 inhibitors versus sulfonylureas using an Intention-To-Treat (ITT) framework, with follow-up censored upon treatment switching to estimate the effect of the initial treatment choice.
Sensitivity Analysis 1 (Active Comparator): A comparison of DPP-4 inhibitors versus SGLT2 inhibitors using the same ITT framework (censoring on switching) to assess the consistency of the results against an alternative second-line antidiabetic class.
Sensitivity Analysis 2 (As-Treated): A comparison of SGLT2 inhibitors versus sulfonylureas using an As-Treated approach, defining continuous use with a permissible gap (grace period) of 60 days between prescriptions to account for adherence patterns.
Significance and Impact Current guidelines for diabetes management prioritize cardiovascular and renal protection. This study aims to expand the clinical evidence base by:
- Providing actionable Real-World Evidence (RWE) on the long-term cancer-related outcomes of diabetes medications.
- Evaluating whether the choice of antidiabetic agents can serve as a strategy for lung cancer prevention in high-risk groups (COPD-T2DM).
- Contributing to the development of comprehensive treatment guidelines that consider cancer prevention alongside metabolic, cardiac, and renal health.
Abbreviation:
COPD, Chronic Obstructive Pulmonary Disease; DPP-4, Dipeptidyl Peptidase-4; ICD-10, International Classification of Diseases, 10th Revision; ICS, Inhaled Corticosteroids; ITT, Intention-To-Treat; LABA, Long-Acting Beta-2 Agonists; LAMA, Long-Acting Muscarinic Antagonists; RWD, Real-World Data; RWE, Real-World Evidence; SABA, Short-Acting Beta-2 Agonists; SAMA, Short-Acting Muscarinic Antagonists; SGLT2, Sodium-Glucose Cotransporter-2; SU, Sulfonylurea; T2DM, Type 2 Diabetes Mellitus;
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment group (main) | – | Drug: SGLT2 inhibitorUsers of SGLT2 inhibitors (for ITT analysis) |
| Active control group (main) | – | Drug: Sulfonylureas (SU)Users of sulfonylureas for ITT analysis |
| Treatment group (S1) | – | Drug: SGLT2 inhibitorUsers of SGLT2 inhibitors (for ITT analysis) |
| Active control group (S1) | – | Drug: Sulfonylureas (SU)Users of DPP4 inhibitors (for ITT analysis) |
| Treatment group (S2) | – | Drug: SGLT2 inhibitorUsers of SGLT2 inhibitors (for as-treated analysis) |
| Active control group (S2) | – | Drug: DPP4 inhibitorsUsers of sulfonylureas (for as-treated analysis) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included adults aged ≥40 years with a prior history of COPD (screened from 2009) and newly diagnosed type 2 diabetes who initiated treatment with either sulfonylureas or SGLT2 inhibitors between January 1, 2014, and December 31, 2023. Type 2 diabetes was defined as having two or more diagnosis records within one year using ICD-10 codes E10-E14. COPD was defined by the presence of ICD-10 codes J43 or J44 (excluding J43.0) concurrent with the prescription of COPD medications at least twice within a year; these medications included long-acting muscarinic antagonists (LAMA), long-acting beta-2 agonists (LABA), ICS plus LABA, short-acting muscarinic antagonists (SAMA), short-acting beta-2 agonists (SABA), SAMA plus SABA, methylxanthines, and systemic beta agonists. In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.
Key inclusion criteria (1 listed)
- Adults aged ≥40 years with prior COPD (from 2009) and newly diagnosed diabetes who initiated SU or SGLT2i between January 1, 2014 and December 31, 2023
Key exclusion criteria (7 listed)
- Pre-existing
- ESRD
- Cancer
- Concurrent prescribing of the study drugs at the index date
- Exposure to the drugs of interest during the year preceding the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorAny new prescription of SGLT2 inhibitors after new onset of T2DM | Drug | Treatment group (S1), Treatment group (S2), Treatment group (main) |
| Sulfonylureas (SU)Any new prescription of sulfonylureas after new onset of T2DM | Drug | Active control group (S1), Active control group (main) |
| DPP4 inhibitorsAny new prescription of DPP4 inhibitors after new onset of T2DM | Drug | Active control group (S2) |
Primary outcome
Lung cancer
Time frame: From index date + 30 days to the end of follow-up
ICD-10 code (C33 or C34) and code for special purposes (V193)
2 secondary outcomes
COPD exacerbation
Time frame: From index date + 30 days to the end of follow-up
Any cancer
Time frame: From index date + 30 days to the end of follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and COPD (Chronic Obstructive Pulmonary Disease), run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung cancer (time frame: From index date + 30 days to the end of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.